Roche recalls Albumin BCP test kits due to calibration failures causing inaccurate albumin measurements. Affected lots may lead to incorrect test results for serum and plasma analysis.
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Roche is recalling Albumin BCP test kits that may give inaccurate albumin measurements due to calibration issues. This could lead to incorrect health assessments if used in medical testing.
The test kits have calibration failures and imprecise quality control due to elevated pH levels. This causes higher absorbance values, leading to inaccurate albumin measurements in blood tests.
Healthcare providers using Roche Albumin BCP test kits for serum and plasma analysis. Patients relying on these tests for accurate albumin measurements may be affected.
Check for Catalog Number 05975573190 and Lot Number 35651401 on the test kit packaging. These kits were sold with Roche/Hitachi cobas c systems.
Look for Catalog Number 05975573190 and Lot Number 35651401 on the test kit packaging.
The test kits have calibration failures and imprecise quality control due to elevated pH levels, causing higher absorbance values and inaccurate albumin measurements.
Check for Catalog Number 05975573190 and Lot Number 35651401 on the test kit packaging. These kits were sold with Roche/Hitachi cobas c systems.
The recall record does not specify a remedy, so contact Roche Diagnostics Corporation for guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1194-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1194-2019 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
